(103 days)
No
The device description details a standard immunochromatographic assay (lateral flow test) which relies on chemical reactions and visual interpretation of lines, not AI/ML algorithms. The performance studies focus on reproducibility and clinical metrics, not the training or testing of an AI/ML model. There are no mentions of AI, ML, DNN, or image processing.
No
The NMP22 BladderChek Test is a diagnostic device used to monitor bladder cancer patients, not to treat them. It aids in diagnosis and monitoring, but does not provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an aid in monitoring bladder cancer patients, in conjunction with standard diagnostic procedures," which indicates a diagnostic purpose. The device also detects the presence of NMP22, a biomarker for bladder cancer, and its performance is evaluated using metrics like sensitivity, specificity, PPV, and NPV, which are characteristic of diagnostic tests.
No
The device description clearly states it is an "immunochromatographic assay utilizing monoclonal antibodies in a lateral flow strip encased in plastic," which is a hardware component. The performance studies also describe testing of physical devices.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's an "aid in monitoring bladder cancer patients, in conjunction with standard diagnostic procedures." This indicates it's used to provide information about a patient's health status.
- Device Description: The description details an "immunochromatographic assay utilizing monoclonal antibodies in a lateral flow strip." This is a common format for in vitro diagnostic tests that analyze biological samples (in this case, urine).
- Input: The device uses "Unprocessed patient urine" as input. Analyzing biological samples is a hallmark of IVDs.
- Mechanism: The mechanism involves detecting the presence of a specific analyte (NMP22) in the urine using antibodies. This is a biochemical process performed outside the body.
- Performance Studies: The document includes detailed performance studies evaluating the device's accuracy (sensitivity, specificity, PPV, NPV) in detecting bladder cancer markers in urine samples. This type of evaluation is required for IVDs to demonstrate their clinical utility.
- Predicate Device: The mention of predicate devices (BTA Stat) which are also IVDs further supports this classification.
Therefore, based on the intended use, device description, input, mechanism, and performance evaluation, the NMP22 BladderChek Test clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Matritech NMP22 BladderChek Test is indicated for professional and prescription home use as an aid in monitoring bladder cancer patients, in conjunction with standard diagnostic procedures.
Product codes
MMW
Device Description
The NMP22 BladderChek Test is an in vitro diagnostic assay for the qualitative detection of the nuclear matrix protein NMP22 in human urine.
The NMP22 BladderChek Test for nuclear matrix protein NMP22 is an immunochromatographic assay utilizing monoclonal antibodies in a lateral flow strip encased in plastic. Two different antibodies are used, one as a capture and one as a reporter antibody. Unprocessed patient urine is added to the sample well of the cartridge and allowed to react with the colloidal gold conjugated reporter antibody. If the antigen is present in urine, it will interact with the reporter conjugate to form an immune complex. The reaction mixture flows through the membrane, which contains zones of immobilized antibodies. In the Test (T) zone, antigen-conjugate complexes are trapped by the capture antibody, forming a visible line if the concentration of antigen in urine is elevated. The procedural Control (C) zone contains an immobilized goat anti-mouse IgG-specific antibody that will capture the conjugated antibody independently of the presence or absence of the antigen, thereby always producing a visible line in the Control window. This procedural control assures the operator that each device is working properly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional and prescription home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Tests:
Reproducibility by Laboratory Technicians: Precision studies were conducted to determine the percent of devices correctly read. Specimen panels with NMP22 levels of 0, 5, 15, and 25 U/mL were used. Three laboratory technicians each read ten devices per level in random order, (40 devices/lab tech) for five different days. This produced 150 individual reads per panel level (3 readers x 10 devices per panel x 5 days). The experiment was conducted on three separate lots of devices. The overall percent of correct reads was 99.2% (1786/1800).
Reproducibility by Lay Users Compared to Professional Readers: A precision study with a three-level precision panel of prepared samples was conducted to evaluate lay user reproducibility. The three levels were targeted to the concentrations of 2, 10 and 15 U/mL. Five lay readers each conducted assays on two blinded and randomized aliquots of the above samples, resulting in a total of ten results per level. In addition, two professional readers each tested five blinded and randomized replicates of the three-level precision panel, producing 10 results for each level. There was 100% concordance among the lay readers, between professional readers, and between the lay and professional readers. All samples at 2 U/mL were read as negative, and all samples at 10 and 15 U/mL were read as positive.
Performance of Lay Users Compared to Professionals: Field studies were conducted at three locations (N=137 total). Professional medical staff re-read the devices used by the lay users, and also conducted their own testing of the volunteers' samples using new devices. There was an overall 96.4% concordance between the results obtained by lay users and professional staff reading the same device, and 95.6% agreement between professional and lay users testing the same urine sample on different devices.
Clinical Tests:
Study Type: Prospective clinical trial.
Sample Size: 668 patients.
Data Source: Voided urine samples were collected from 668 patients prior to surveillance cystoscopy at 23 sites. Clinical staff performed the testing. Physicians conducting the cystoscopies were blinded to the device results.
Key Results:
Sensitivity for patients with bladder cancer was 45.9% (45/98).
Specificity for individuals with no evidence of disease was 83.9% (234/279).
Overall Sensitivity: 45.9% (35.8%, 56.3%) (45/98).
Overall Specificity: 86.3% (83.2%, 89.0%) (492/570).
Positive Predictive Value: 36.6% (28.1%, 45.8%) (45/123).
Negative Predictive Value: 90.3% (87.5%, 92.6%) (492/545).
Sensitivity by Tumor stage:
Ta- Tl: 40.0% (22/55)
T2- T3: 80.0% (4/5)
Tx: 51.4% (19/37)
Sensitivity by Tumor grade:
Well differentiated (Grade 1): 30.0% (9/30)
Moderately differentiated (Grade 2): 33.3% (4/12)
Poorly differentiated (Grade 3 or Grade 4): 66.7% (12/18)
Gx (Grade unknown): 52.6% (20/38)
Concordance of NMP22 BladderChek and NMP22 Test Kit (microplate):
Voided urine samples were collected from 217 individuals. An aliquot of each sample was applied to a BladderChek Test device. An additional aliquot was stabilized immediately and tested by the Matritech NMP22 (microplate) Test Kit to quantify the NMP22 concentration. Overall concordance was 91.2% (198/217, CI 86.7%, 94.7%), with a positive concordance of 87.0% (20/23, CI 66.4%, 97.2%) and negative concordance of 91.8% (178/194, CI 86.9%, 95.2%).
Key Metrics
Sensitivity: 45.9% (35.8%, 56.3%) (45/98)
Specificity: 86.3% (83.2%, 89.0%) (492/570)
Positive Predictive Value: 36.6% (28.1%, 45.8%) (45/123)
Negative Predictive Value: 90.3% (87.5%, 92.6%) (492/545)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
0
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K021231
| Name: | Matritech, Inc.
330 Nevada St.
Newton, MA 02460 |
|--------------------------|----------------------------------------------------------------------------------------|
| Contact: | Melodie R. Domurad PhD
617 928 0820 ext 265
mdomurad@matritech.com |
| Date: | April 15, 2002 |
| Catalog Number: | D1200 24-test kit
D1201 1-test kit
D1250 Control kit |
| Device Name: | NMP22® BladderChek™ Kit
NMP22® Control Kit |
| Common: | NMP22 BladderChek |
| Classification: | Class II |
| Manufacturer: | Unotech Diagnostics, Inc.
2235 Polvorosa Ave.
Suite 220
San Leandro, CA 94577 |
| Registration Number: | 1225597 Matritech, Inc.
2953160 Unotech Diagnostics, Inc |
| Substantially Equivalent | RTA Stat Test |
Predicate Device
Description of Device
The NMP22 BladderChek Test is an in vitro diagnostic assay for the qualitative detection of the nuclear matrix protein NMP22 in human urine.
1
Intended Use
The Matritech NMP22 BladderChek Test is indicated for professional and prescription home use as an aid in monitoring bladder cancer patients, in conjunction with standard diagnostic procedures.
Summary and Explanation of the Test
The NMP22 BladderChek Test for nuclear matrix protein NMP22 is an immunochromatographic assay utilizing monoclonal antibodies in a lateral flow strip encased in plastic. Two different antibodies are used, one as a capture and one as a reporter antibody. Unprocessed patient urine is added to the sample well of the cartridge and allowed to react with the colloidal gold conjugated reporter antibody. If the antigen is present in urine, it will interact with the reporter conjugate to form an immune complex. The reaction mixture flows through the membrane, which contains zones of immobilized antibodies. In the Test (T) zone, antigen-conjugate complexes are trapped by the capture antibody, forming a visible line if the concentration of antigen in urine is elevated. The procedural Control (C) zone contains an immobilized goat anti-mouse IgG-specific antibody that will capture the conjugated antibody independently of the presence or absence of the antigen, thereby always producing a visible line in the Control window. This procedural control assures the operator that each device is working properly.
Substantial Equivalence to Predicate Device
Both the NMP22 BladderChek Test and BTA Stat are single use, in vitro diagnostic devices for detecting recurrence in patients with a history of bladder cancer. The assay reactions for the two devices are immunochromatographic, utilizing monoclonal antibodies, and produce qualitative results. Both detect analytes from voided urine. Targeted environment for the two tests is prescription home use. The NMP22 BladderChek Test detects the nuclear matrix protein NMP22, and the BTA Stat Test detects Bladder Tumor Antigen.
2
| | NMP22 BladderChek
K021231 | BTA Stat
K974845 & K964151 |
|-----------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Intended Use | Aid in the monitoring of bladder
cancer patients in conjunction
with standard diagnostic
procedures | Aid in the management of
bladder cancer patients in
conjunction with cystoscopy |
| Sample Matrix | Voided urine | Voided urine |
| Procedural Steps | Add 4 drops of urine | Add 5 drops of urine |
| Result Interpretation | +/-, Qualitative | +/-, Qualitative |
| Analyte Measured | NMP22
Nuclear Matrix Protein | BTA
Bladder Tumor Antigen |
| Targeted Environment | Professional and Prescription
Home Use | Laboratory and Prescription
Home Use |
| Assay Reaction | Immunochromatographic | Immunochromatographic |
Non-Clinical Tests
Reproducibility by Laboratory Technicians
Precision studies were conducted to determine the percent of devices correctly read. Specimen panels with NMP22 levels of 0, 5, 15, and 25 U/mL were used. Three laboratory technicians each read ten devices per level in random order, (40 devices/lab tech) for five different days. This produced 150 individual reads per panel level (3 readers x 10 devices per panel x 5 days). The experiment was conducted on three separate lots of devices.
The percent of correctly read NMP22 BladderChek devices was very consistent across lots (n=3), lab techs (n=3), and days (n=5), where urine specimens with NMP22 levels of 0 and 5 U/mL should have been read as negative and urine specimens with NMP22 levels of 15 and 25 U/mL should have been read as positive.
The overall percent of correct reads was 99.2% (1786/1800). Twelve of the 14 incorrect results were at 5 U/mL (438/450 or 97%), which could be expected near the test cut-off.
3
Reproducibility by Lay Users Compared to Professional Readers
A precision study with a three-level precision panel of prepared samples was conducted to evaluate lay user reproducibility. The three levels were targeted to the concentrations of 2, 10 and 15 U/mL to represent negative, low positive and positive values. Five lay readers each conducted assays on two blinded and randomized aliquots of the above samples, resulting in a total of ten results per level. In addition, two professional readers each tested five blinded and randomized replicates of the three-level precision panel, producing 10 results for each level. There was 100% concordance among the lay readers. between professional readers, and between the lay and professional readers. All samples at 2 U/mL were read as negative, and all samples at 10 and 15 U/mL were read as positive.
Performance of Lay Users Compared to Professionals
Field studies to evaluate the ability of lay users compared to professional users of the BladderChek test were conducted at three locations. Each volunteer, aged 50 years or older, some with a history of bladder cancer, tested his or her own urine with one device. At each site professional medical staff re-read the devices used by the lay users, and also conducted their own testing of the volunteers' samples using new devices.
To ensure the presence of some positive results in the study, fourteen samples were spiked with NMP22 to approximately 15 U/mL and fourteen with approximately 25 U/mL. In addition, eight devices were made invalid by not having a working control line.
There was an overall 96.4% concordance between the results obtained by lay users and professional staff reading the same device, and 95.6% agreement between professional and lay users testing the same urine sample on different devices. All spiked specimens were read correctly by lay and professional readers.
| | Percent Overall Concordance
with Lay User Result | | | |
|---------------------------------------------------------------------------------------|-----------------------------------------------------|------------------|------------------|--------------------|
| | Site 1
(N=55) | Site 2
(N=35) | Site 3
(N=47) | Overall
(N=137) |
| Professional Re-testing of same urine
sample with new NMP22 BladderChek™
Device | 96.4%
(53/55) | 97.1%
(34/35) | 93.6%
(44/47) | 95.6%
(131/137) |
| Professional Re-Read of Lay User
NMP22 BladderChek™ Device | 96.4%
(53/55) | 100%
(35/35) | 93.6%
(44/47) | 96.4%
(132/137) |
4
Clinical Tests
A prospective clinical trial was performed at 23 sites to determine the utility of NMP22 BladderChek as an aid in monitoring patients with a history of bladder cancer. Voided urine samples were collected from 668 patients prior to surveillance cystoscopy, and clinical staff performed the testing. Physicians conducting the cystoscopies were blinded to the device results.
To determine the sensitivity and specificity, patients were classified as positive or negative for bladder cancer. Patients were considered negative if no tumor was seen endoscopically, or, if a lesion was seen, was pathologically determined to be nonmalignant. There were 291 patients diagnosed as having benign disease(s), and 279 with no evidence of urinary tract disease. Patients were considered positive for bladder cancer if a tumor was seen during cystoscopy, and, if removed was pathologically determined to be malignant. There were 98 recurrences of neoplasms, of which 61 were resected and had stage and grade information available. The remaining 37 patients did not undergo surgical removal, and therefore their tumors could not be staged or graded (Tx, Gx).
5
Specificity for individuals with no evidence of disease, benign disease by group, history of non-bladder cancer, and active cancers other than of the bladder is presented in the following table.
| Specificity | (95% CI) | |
|---|---|---|
| Patients with No Evidence of | ||
| Disease | ||
| (History of Bladder Cancer) | 83.9% | |
| (234/279) | (79.0%, 88.0%) | |
| Benign Diseases* | ||
| BPH/prostatitis | 89.6% | |
| (120/134) | (83.1%, 94.2%) | |
| Cystitis/inflammation/trigonitis/UTI | 85.2% | |
| (23/27) | (66.3%, 95.8%) | |
| Erythema | 92.5% | |
| (49/53) | (81.8%, 97.9%) | |
| Hyperplasia/squamous metaplasia/ cysts | ||
| and polyps | 82.4% | |
| (14/17) | (56.6%, 96.2%) | |
| Calculi | 100% | |
| (5/5) | (47.8%, 100%) | |
| Trabeculations | 89.1% | |
| (106/119) | (82.0%, 94.1%) | |
| Other benign diseases, kidney and | ||
| genitourinary | 86.4% | |
| (51/59) | (75.0%, 94.0%) | |
| Cancer History, non-bladder - | ||
| Inactive Other Cancers^ | 88.8% | |
| (71/80) | (79.7%, 94.7%) | |
| Cancer History, non-bladder - | ||
| Active Other Cancers^^ | 71.4% | |
| (5/7) | (29.0%, 96.3%) |
*Patients may have more than one benign disease
^ Types of cancers: prostate (n=29), skin (n=18), kidney/renal (n=15), genitourinary, non-bladder, non-prostate (n=5), breast (n=6), GI (n=6), lung/respiratory (n=4), blood (n=1), other (n=3).
^ Patients may have more than one type of prior cancer, and current benign diseases. ^^ Types of cancers: prostate (2/4), 1 kidney (0/1), 1 cervical (0/1), 1 lung/liver (0/1)
Sensitivity for patients with bladder cancer was 45.9%. Patients were considered positive for bladder cancer if a tumor was seen during cystoscopy, and, if removed, was pathologically determined to be malignant.
| Cystoscopy | NMP22 BladderChek Test | ||
|---|---|---|---|
| Negative | Positive | Total | |
| Negative | 492 | 53 | 545 |
| Positive | 78 | 45 | 123 |
| Total | 570 | 98 | 668 |
6
| | Sensitivity
(95% Exact CI) | Specificity
(95% Exact CI) | Positive Predictive
Value
(95% Exact CI) | Negative Predictive
Value
(95% Exact CI) |
|---------------------------------------|------------------------------------|--------------------------------------|------------------------------------------------|------------------------------------------------|
| NMP22
BladderChek vs
Cystoscopy | 45.9%
(35.8%, 56.3%)
(45/98) | 86.3%
(83.2%, 89.0%)
(492/570) | 36.6%
(28.1%, 45.8%)
(45/123) | 90.3%
(87.5%, 92.6%)
(492/545) |
Overall sensitivity and specificity for the clinical trial was as follows.
The NMP22 BladderChek test was more sensitive to later stages and higher grades of cancer, although the majority of malignancies were non-invasive. Sensitivity by stage and grade is detailed in the table below.
| | Sensitivity of NMP22
BladderChek Test | (95% CI) |
|------------------------------------------------------------|------------------------------------------|----------------|
| Tumor stage: Ta- Tl | 40.0%
(22/55) | (27.0%, 54.1%) |
| Tumor stage: T2- T3 | 80.0%
(4/5) | (28.4%, 99.5%) |
| Tumor stage: Tx | 51.4%
(19/37) | (34.4%, 68.1%) |
| Tumor grade: Well differentiated
(Grade 1) | 30.0%
(9/30) | (14.7%, 49.4%) |
| Tumor grade: Moderately differentiated
(Grade 2) | 33.3%
(4/12) | (9.9%, 65.1%) |
| Tumor grade: Poorly differentiated
(Grade 3 or Grade 4) | 66.7%
(12/18) | (41.0%, 86.7%) |
| Tumor grade: Gx
(Grade unknown) | 52.6%
(20/38) | (35.8%, 69.0%) |
The incidence rate for bladder cancer recurrence in this study was 14.7%. The following table demonstrates the Positive (PPV) and Negative (NPV) predictive values of the NMP22 BladderChek test at varying incidence rates.
| Incidence
| Rate | NMP22 BladderChek Test | |
|---|---|---|
| Sensitivity=45.9% | ||
| Specificity=86.3% | ||
| PPV | NPV | |
| 10% | 27.1% | 93.5% |
| 14.7%* | 36.6% | 90.3% |
| 20% | 45.6% | 86.5% |
| 30% | 58.9% | 78.8% |
- Actual incidence rate from NMP22 BladderChek Monitoring Study
Concordance of NMP22 BladderChek and NMP22 Test Kit (microplate)
In comparison testing using voided urine samples, the NMP22 BladderChek Test showed good concordance with the NMP22 Test Kit (microplate).
Voided urine samples were collected from 217 individuals at urology clinics. An aliquot of each sample was applied to a BladderChek Test device. An additional aliquot was stabilized immediately and tested by the Matritech NMP22 (microplate) Test Kit to quantify the NMP22 concentration.
7
Overall concordance was 91.2% (198/217, CI 86.7%, 94.7%), with a positive concordance of 87.0% (20/23, CI 66.4%, 97.2%) and negative concordance of 91.8% (178/194, CI 86.9%, 95.2%).
| NMP22 Microplate | NMP22 BladderChek Test | ||
|---|---|---|---|
| Assay | Negative | Positive | Total |
| Negative (≤10 U/mL) | 178 | 16 | 194 |
| Positive (> 10 U/mL) | 3 | 20 | 23 |
| Total | 181 | 36 | 217 |
Conclusion
The NMP22 BladderChek Test and its predicate device, the BTA Stat are technologically similar. The assay reactions (immunochromatography utilizing monoclonal antibodies), sample matrix (voided urine), procedural steps (addition of drops of urine to device), result interpretation (qualitative +/-), patient population (history of bladder cancer), and indication (aid in monitoring), are all similar.
Reproducibility of results with NMP22 BladderChek were excellent between laboratory technicians across lots, days and specimen panel levels. Overall percent of correct reads was 99.2%. A precision study using a prepared specimen panel of negative (2 U/mL). low positive (10 U/mL) and positive (15 U/mL) samples demonstrated 100% concordance between professional staff (n=2) and lay users (n=5). In addition, an investigation to evaluate performance of lay users compared to professional readers showed 96.4% overall concordance when professionals re-read tests performed by lay volunteers using their own urine, and 95.6% when the professionals re-tested the lay users' urine samples. The BTA Stat package insert states that reproducibility studies were performed to determine day-to-day, reader, lot-to-lot, and laboratory-tolaboratory variability. It reports that these studies showed nearly total agreement with the exception of samples near the limit of detection, thus non-clinical performance of the two devices is comparable.
In the prospective clinical trial performed with NMP22 BladderChek sensitivity was 45.9% (CI 35.8%, 56.3%) and specificity was 86.3% (CI 83.2%, 89.0%), with a positive predictive value of 36.6% (CI 28.1%, 45.8%) and a negative predictive value of 90.3% (C1 87.5%, 92.6%). The incidence rate of cancer in the study population was 14.7%. Per its package insert, BTA Stat demonstrated 67% (CI 60%, 73%) sensitivity and 70% (CI 61%, 79%) specificity. Because the performance for this device was determined using retrospective samples selected from a frozen bank, incidence rate could not be determined, so true positive and negative predictive values could not be calculated.
8
Using a range of theoretical incidence rates of 10%, 20% and 30%, the NMP22 BladderChek Test demonstrated positive predictive values of 27.1% to 58.9%, compared to 19.8% to 48.8% for BTA Stat. In addition, the overall accuracy (defined as test positive for patients with cancer and test negative for patients without cancer divided by the total number of patients) of NMP22 BladderChek was 80.3% compared to 67.9% for BTA Stat. This was due in part to the excellent specificity of BladderChek, resulting in fewer false positive results.
The non-clinical and clinical studies presented in this submission demonstrate that the clinical utility and performance of NMP22 BladderChek is equivalent or better than that of the predicate device, BTA Stat.
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right, with three parallel lines above them. The seal is black and white.
JUL 3 0 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Melodie R. Domurad. Ph.D. Vice President. Clinical and Regulatory Affairs Matritech, Inc. 330 Nevada Street Newton, Massachusetts 02460
Re: K021231 Trade/Device Name: NMP22® BladderChekTM Test Regulation Number: 21 CFR § 866.6010 Regulation Name: Tumor Marker Test Systems - Monitoring-Bladder Regulatory Class: II Product Code: MMW Dated: June 27, 2002 Received: June 28, 2002
Dear Dr. Domurad:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
10
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
11
INDICATION FOR USE STATEMENT
510(k) Number: K 021231
长021231
Device Name: NMP22® BladderChek™ Test
Indication For Use:
The NMP22 BladderChek test is indicated for use as an aid in monitoring bladder cancer patients, by professional and prescription home use, in conjunction with standard diagnostic procedures.
JP Reeve for S. Altaie
(Division Sign Division of Clinical Laboratory Devices
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use
2.1